NEXPLANON

  1. INTRODUCTION

NEXPLANON®is a long-term (3 year), reversible hormonal contraceptive subdermal implant that contains 68mg etonogestrel (progesterone-only). NEXPLANON® is a sterile single rod 4 cm in length and 2 mm wide and does not contain latex. The NEXPLANON rod initially releases between 60-70 mcg per day but declines slowly over time (etongestrel blood levels inhibit ovulation for at least three years in most women). NEXPLANON®is radio-opaque therefore is visible on x-ray and CT scan. Mechanisms of action include suppression of ovulation, increased viscosity of cervical mucosa and alterations in the endometrium. NEXPLANON®training for inserting and removal by a manufacturer-approved trainer is required prior to health care professionals providing this contraceptive method. Fewer than one woman out of 100 becomes pregnant in the first year of using IUDs (typical use).

  1. CLIENT SELECTION

A.Indications – NEXPLANON®may be provided when contraindications do not exist

1.For contraception

2.When a woman cannot use, or has medical contraindications to, estrogen-containing methods

B.Contraindications

(CDC 3—Risks outweigh advantages for method use; CDC 4—Unacceptable risk for method use)

1.Current or past history of ischemic heart disease (CDC 3for continuation)

2.Liver tumors (benign hepatocellular or malignant hepatoma) (CDC 3)

3.Cirrhosis (severe-decompensated) (CDC 3)

4.Unexplained vaginal bleeding (before evaluation) (CDC 3)

5.Breast cancer (current, CDC 4)(past and no evidence of current disease for 5 years, CDC 3)

6.Systemic Lupus Erythematous – positive (or unknown) antiphospholipid antibodies (CDC 3)

7.Stroke (history of cerebrovascular accident) (CDC 3 for continuation)

  1. MANAGEMENT OF WOMEN WITH SPECIAL CONDITIONS REQUIRING FURTHER EVALUATION

A.Decisions regarding individualized management, follow-up intervals, the need for additional testing or referral must be made based on protocols approved by the Medical Director. In addition, there should be consultation with the Medical Director if needed. These medical conditions include:

1.Migraine with aura that develops during NEXPLANON®(WHO 3)

2.Efficacy in overweight women has not been studied (PI)

  1. MEDICAL SCREENING AND EVALUATION

A.Comprehensive medical data base (history, physical examination, and laboratory testing as indicated) should be completed prior to provision of NEXPLANON®.

B.Deferred Exam: Physical exam and related preventative services should not be deferred beyond 3 months after the initial visit and may not be deferred beyond 6 months (unless there is a compelling reason for extending the deferral in the clinician’s judgment). Pelvic exams are not required until 21 y/o unless indicated (ACOG). The reason for the deferral must be documented in the client’s medical record. A complete history and BP is required in the medical record.

C.Written results of a physical exam done elsewhere within the last 12 months are acceptable. MDCH Pap test screening protocol guidelines must be followed. Clients transferring from another provider must have a blood pressure measurement prior to receivingNEXPLANON®.

  1. CLIENT EDUCATION/INFORMED CONSENT

A.Must include:

1.Information/counseling regarding all contraceptive options available

2.Information specific to NEXPLANON® ,including contraceptive effectiveness, mechanism of action, benefits, risks, use, danger signs, potential side effects, complications, and discontinuing issues.

3.Signed Consent Form

4.Information that NEXPLANON®provides no protection against sexually transmitted infections (STIs or HIV).

5.Advising the client to read the Patient Package Insert (PPI)

B.The Client must be given:

1.Written and verbal instruction on method use (may use package insert)

2.A copy of the FDA-approved Patient Package Insert (PPI)

3.User card in the NEXPLANON®kit (write in insertion date, lot #, removal date)

4.Emergency 24-hour telephone number and location where emergency services can be obtained

5.Clinic access information

C.Timing of Initiation – The table below should be followed when initiating NEXPLANON®. Alternative timings must be individualized to ensure contraceptive protection.

Current Method / NEXPLANON® Insertion / Back-Up
None
(in the past month) / Day 1 thru 5 of the menstrual cycle / If more than 5 days since menstrual bleeding started, back up for 7 days
Combination Hormonal Contraceptive
  1. COC
  1. Ring
  2. Patch
  1. POP
/ *Note: can insert NEXPLANON®anytime in cycle if R/O pregnancy)
  1. Anytime within 7 days of the last active COC pill
  1. Anytime during the 7 day ring-free period
  1. Anytime during the 7 day patch-free period
  2. Any day of the month (has not skipped any days between the last pill and insertion of NEXPLANON®)Insert within 24 hours of taking last tablet
/ None
If timing deviations occur, use back up method for 7 days after insertion
NEXPLANON® / On same day implant is removed / None
DMPA / On or before next injection is due / None
IUCs / Any time in cycle (assure not pregnant)
Within first 5 days of menses (remove IUC same day)
Beyond first 5 days of menses (admits to sexual intercourse this cycle)—delay removal of IUC until next menses
Beyond first 5 days of menses (admits to no sexual intercourse this cycle) / None
Delay removal of IUC until next menses
Barrier method for 7 days
1st trimester abortion or miscarriage /
  1. Within first 5 days following a complete first trimester abortion or miscarriage
  2. If beyond 5 days following complete first trimester abortion, follow instructions for “not using hormonal contraceptive use in past month”
/ None
Post-partum or second trimester abortion or miscarriage /
  1. Between 21-28 days post-partum (if not exclusively breast feeding)
  1. Between 21-28 days following second trimester abortion (no intercourse)
  1. If > 4 weeks post-partum (and exclusively breastfeeding), assure client is not pregnant
/ None
Backup for 7 days
Backup for 7 days with non-hormonal method
Post-Partum
a. Not breastfeeding
b. Breastfeeding /
  1. Between 21-28 days (if no intercourse)
  1. If > 4 weeks post-partum (assure client is not pregnant)
/ None
Barrier methodfor 7 days
  1. MANAGEMENT OF SIDE EFFECTS AND COMPLICATIONS

A.Irregular Vaginal Bleeding (heavy, prolonged or spotting)—Clients are likely to have changes in their vaginal bleeding patterns. The unpredictable changes include frequency or duration or amenorrhea. An average of 17.7 days of bleeding or spotting every 90 days. Also consider the following:

1.Pregnancy test if indicated

2.Hgb. test if indicated (10 gm/dl, consult with medical director)

3.Chlamydia and GC testing if at high risk or indicated

4.Pelvic exam if persistent bleeding

5.If no pathology is found, counsel client re: irregular bleeding as an adverse reaction, discuss removal option

6.If cause identified, treat as indicated

7.If cause not identified, reassure client bleeding patterns are not dangerous and may resolve with time, consult with medical director or refer for evaluation

B.Ectopic Pregnancy—Clients who become pregnant using NEXPLANON®are more likely to be ectopic and should be monitored for an ectopic if lower abdominal pain occurs

C.Weight Gain—In clinical trials, 6.4% gained weight with an average of 2.8 pounds after 1 year and 3.7 pounds after 2 years.

D.Carbohydrate and Lipid Metabolic Effects— NEXPLANON®may induce mild insulin resistance and small changes in glucose concentrations. Women with diabetes or impaired glucose tolerance must be carefully observed by the provider managing the diabetes.

E.Liver Function—If jaundice develops using NEXPLANON®,removal is recommended as the hormone in NEXPLANON®may be poorly metabolized in clients with impaired liver function.

F.Depression—Clients with a history of depression should be monitored and NEXPLANON®removed if depression becomes significantly increased.

G.Contact Lens Users—Clients who develop visual changes or changes in lens tolerance should be referred to an ophthalmologist for assessment.

H.Headache – In clinical trials, 24.9% of NEXPLANON®users reported headache as an adverse event. Obtain a headache history and determine if headache is migraine with aura and if so, removal is recommended.

  1. FOLLOW-UP

A.Post-insertion site check is not indicated unless the client has signs of infection at the site (red, inflamed, discharge) or other NEXPLANON® -related complications

B.Advise the client to report any of the following:

1.Unable to palpate rod

2.Heavy vaginal bleeding (lasting 14 days or longer)

3.Delayed menses after a long interval of regular cycles

4.Concern about possible pregnancy

5.Arm pain, redness, bleeding/discharge at the insertion site

6.Onset/worsening of migraine, aura, or severe headache

7.Desire for removal

C.Annual exams are to be scheduled by the client.

D.Removal—when method change desired, pregnancy desired, or NEXPLANON®has reached expiration date (3 years):

1.Follow removal guidelines in the manufacturer’s package insert

2.Removal consent is needed

3.Counsel the client as indicated on alternate contraceptive methods or provide pre-pregnancy health care information, if pregnancy is desired.

4.If client desires another NEXPLANON®,insertion may occur immediately upon removal of the current NEXPLANON®

5.Service sites (clinics) that do not provide NEXPLANON® (insertion or removal) must refer the client to a local provider

  1. DOCUMENTATION

A.Order must be documentedin medical record

B.Document inthe medical record and/or client’s user card:

1.Date of the insertion

2.Type and amount of topical anesthetic

3.3-year removal date

4.Location (left or right arm)

5.Client identification (ID) number

6.Lot number

7.Expiration date of implant

8.Name of inserter

C.Removal Documentation

1.Reason for removal

2.Type and amount of topical anesthetic

3.Length of incision

4.Any problems encountered

5.Site care instructions provided

D.All education/counseling must be documented

References:

CDC U.S. Selected Practice Recommendations for Contraceptive Use, 2013

CDC Medical Eligibility Criteria for Contraceptive Use. MMWR, Vol 59, No. RR-4, June 18, 2010

Manufacturers FDA approved Patient Package Insert (PPI)

Revised 1/2014

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